It is time for a SYNTAX-like trial for transcatheter valves

28th January 2011

341

By Pieter Kappetein

The SYNTAX trial compared percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) for treating patients with previously untreated three-vessel or left main coronary artery disease (or both). A heart team discussion was essential for deciding which patients need coronary surgery, which should have percutaneous catheter intervention, and which could be randomised to surgery or PCI. Patients were randomised when both the cardiologist and the surgeon were in doubt as to what the best treatment was.

The SURTAVI trial will use the same concept, with a heart team deciding which patients can be randomised to transcatheter aortic valve implantation (TAVI) with the CoreValve device or to surgical aortic valve replacement.

Patients likely to have a good result with surgery will be operated on while those at high risk for surgery (90 years old with many comorbidities, for example) will have TAVI. The transcatheter heart valve could be an alternative for patients at intermediate risk for surgery and it is this group who will be randomised.

So far, trials and registries on transcatheter heart valves have only included patients who were inoperable or at high risk for surgery. But the use of transcatheter heart valves is expanding with more than 25,000 implants to date. Three types of intermediate risk patients will be discussed for randomisation by the heart team: 80-year-olds without comorbidities; 75-year-olds with more than one cormorbidity; and 70-year-olds with two comorbidities. Patients under 70 years of age will not be randomised because of insufficient evidence on the durability of the percutaneous heart valves.

SURTAVI needs to randomise around 1,100 patients, which means 550 for surgery and 550 for transcatheter heart valves. Only centres with enough experience of transcatheter heart valves (at least 30 valve implants) will be eligible to participate and around 35–40 sites in Europe will be needed. The aim is to start enrolling patients in the second quarter of 2011. US sites may be added later.

The primary endpoint in the SURTAVI trial is mortality and stroke. Secondary endpoints include valve failure, endocarditis and regression of the left ventricle. Valve registries have shown a higher pacemaker implantation rate (up to 25%) compared to surgery (1–2%) and this will also be monitored.

The study aims to show that TAVI treatment is non-inferior to surgery. If it is shown to be non-inferior, TAVI could be preferable for an 80-year-old who would avoid having the chest opened and being put on a heart lung machine. Patients who receive surgery stay in hospital longer and take 3–4 months to recover which is quite a long time within an average of seven years to live. It is hoped that the intermediate risk population will recover more quickly after TAVI than surgery and be discharged earlier from hospital.

The SURTAVI trial includes a cost-effectiveness analysis which will look at number of days in hospital, number of ICU days, cost of the valve, other medications used, etc.

The recruitment period will take some time and the primary endpoint is therefore expected in three years from now. Hopefully the SURTAVI trial will offer us guidance on how to treat intermediate risk patients: with surgical aortic valve replacement or with transcatheter valve implantation. The physicians forming the executive committee of the SURTAVI trial are Patrick Serruys, Stephan Windecker, Thomas Walther, Ruediger Lange and Pieter Kappetein.